Class 2 Device Recall Mainline confirms pregnancy test

• Date Initiated by Firm: October 07, 2009
• Date Posted: March 08, 2010
• Recall Status: Terminated on February 04, 2011
• Recall Number: Z-1018-2010
• Recall Event ID: 54131
• Product Classification: Pregnancy test - Product Code LCX
• Product: Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
• Code Information: Lot 25310 and 25831.
• Recalling Firm/ Manufacturer: Mainline Technology, Inc.; 3985 Research Park Dr; Ann Arbor MI 48108-2282
• Manufacturer Reason for Recall: Lack of assurance of safety and efficacy: unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expirations dates.
• FDA Determined Cause: PMA
• Action: Consignees were notified via recall letters dated October 7, 2009 to cease using and to return the recalled products to Mainline Technology. Direct questions about the recall to Mainline Technology by calling 1-800-541-4467 or 1-734-930-2043.
• Quantity in Commerce: Information not provided.
• Distribution: Worldwide Distribution -- United States, Belgium and Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.